Laidlaw Reiterates Buy Rating on Nuvectis Pharma (NVCT) with $35 Price Target
This morning, NVCT reported that their recently in-licensed NXP100 (HSK39297 or ciprocopan), a once-daily, oral complement factor B inhibitor (CFBi), has been approved in China as a paroxysmal nocturnal hemoglobinuria (PNH) treatment by the original developer, Haisco Pharmaceutical Group (海思科医药). Our take is the approval in China, although not a total surprise given the robust Phase III study results, is additional validation of ciprocopan’s potential in treating PNH. With the increasing use of oral CFBi treating PNH, a once daily NXP100, if approved in the U.S., could have a potential compliance advantage. Ciprocopan (Chinese brand name 优可盼), received marketing approval from the NMPA of China as a 1st-line treatment in PNH patients previously untreated with complement inhibitors. Ciprocopan is a first global approved once-daily, orally administered CFBi. The 1st-line therapy approval is based on a randomized comparative study between NXP100 and eculizumab. The study met its primary endpoint with robust results. Ciprocopan also is seeking approval as a 2nd-line PNH treatment in China based on study results in C5 inhibitor-failed patients. This study also met its primary endpoint. A ciprocopan in nephropathy (IgAN) Phase III trial in China is ongoing, supported by promising Phase II study results. Going forward, NVCT is scheduled to finish tech transfer and with plans to complete an IND filing in late 2026 with initial clinical studies potentially starting in 1H27. Given its potential as an effective CFBi, in addition to the ongoing Chinese clinical studies for 2nd-line PNH and IgAN, NXP100 could be a pipeline product for NVCT. A globally approved oral CFBi, Fabhalta (iptacopan) by NVS could be another validation. It is indicated for PNH, IgAN and C3G, with 2025 annual sales of $505MM (291% Y/Y increase). We are reiterating our Buy rating and $35 target price.
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